TIVICAY (dolutegravir) is an INSTI (Integrase Strand Transfer Inhibitor), which is a drug that is used for the treatment of HIV. It is used in patients who are INSTI-naïve as part of a combination regimen with other antiretrovirals, or for INSTI-exposed adults with certain profiles of HIV resistance. The completion of the infectious virus is disrupted by dolutegravir, which inhibits the action of the HIV replication enzyme integrase.
Dosing & Administration
TIVICAY is used in combination with other antiretroviral drugs and may be used in adults and children weighing 30 kg or more. TIVICAY is available in film-coated tablets, which may be scored or crushed. It can be taken with or without food. TIVICAY requires dosage increases when used with certain other medications. This drug is used to treat HIV and off-label for HIV post-exposure prophylaxis following occupational or non-occupational exposure, including sexual assault. Patient selection for TIVICAY therapy faces limitations, so refer to current guidelines for details. Further dosages and prescribing considerations are explained in the package insert.
TIVICAY should not be used in severe hepatic impairment but can be used without dosage adjustment in patients with mild or moderate hepatic impairment. Patients with mild to moderate renal dysfunction do not need an adjustment to their dose but added caution and dosage changes are needed for patients with severe renal impairment. Further details are provided in the package insert.
TIVICAY is contraindicated in patients who are hypersensitive to the drug, or those take dofetilide.
TIVICAY is associated with potential side effects: viral resistance, osteonecrosis, hepatotoxicity, immune reactivation syndrome, and a rash. A more complete list of side effects is available in the package insert.
There have been serious, even fatal rashes and organ dysfunction related to hypersensitivity reactions reported in patients taking TIVICAY.
TIVICAY is linked with an increased risk of depression and suicidal ideation/behavior, especially for patients who have a pre-existing psychiatric illness.
All patients who test positive for HIV infection should be screened for comorbid HBV and HCV infections. Regardless of CD4 counts or viral loads, co-infected patients should be started on an antiretroviral regimen targeting co-infected viruses. Drug regimens and prescribing considerations are outlined in the current HIV treatment guidelines.
The use of other drugs and herbal remedies causes potential interactions, and contraindications. Further details about other drugs and the use of TIVICAY is listed in the package insert.
Pregnancy & Lactation
Regardless of viral load and CD4 count, highly active retroviral combination treatment should be used in all pregnant women. Current guidelines should be consulted when treating pregnant women or women who may become pregnant, as TIVICAY is associated with neural tube defects when used in the first trimester of pregnancy. To protect the infant, the CDC recommends that women with HIV should not breastfeed.
TIVICAY overdose should be treated with close monitoring and standard supportive care. Dolutegravir is not dialyzable.
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